Releases Details
Filing of Form 10-Q
A copy of the Form 10-Q, is included in the appendix below and has also been posted to the Company's website, https://investors.maxcyte.com/.
About
MaxCyte Contacts:
|
+1 301-944-1660 |
US IR Adviser |
+1 415-937-5400
|
Nominated Adviser and Joint Corporate Broker Panmure Gordon Corporate Broking |
+44 (0)20 7886 2500 |
|
+44 (0)203 709 5700
|
Appendix
SECURITIES AND EXCHANGE COMMISSION
FORM 10‑Q
(Mark one)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from___ to___
Commission file number: 333‑257810
(Exact name of registrant as specified in its charter)
|
|
|
|
|
52‑2210438 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
(Address of principal executive offices)
Registrant's telephone number, including area code: (301) 944‑1700
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of each class |
Trading Symbol(s) |
|
Common stock, par value |
MXCT |
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☐ No☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b‑2 of the Exchange Act.
|
|
|
|
|
|
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
Smaller reporting company |
☐ |
Emerging growth company |
☒ |
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act). Yes ☐ No ☒
As of
Table of Contents
|
Page No |
|
PART I. FINANCIAL INFORMATION |
7 |
|
Item 1. |
Financial Statements (Unaudited) |
7 |
|
Condensed Consolidated Balance Sheets |
7 |
|
Condensed Consolidated Statements of Operations |
8 |
|
Condensed Consolidated Statements of Changes in Stockholders' Equity |
9 |
|
Condensed Consolidated Statements of Cash Flows |
10 |
|
Notes to Unaudited Condensed Consolidated Financial Statements |
11 |
Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
20 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
32 |
Item 4. |
Controls and Procedures |
33 |
PART II. OTHER INFORMATION |
34 |
|
Item 1. |
Legal Proceedings |
34 |
Item 1A. |
Risk Factors |
34 |
Item 2. |
Unregistered Sales of |
34 |
Item 3. |
|
34 |
Item 4. |
Mine Safety Disclosures |
34 |
Item 5. |
Other Information |
35 |
Item 6. |
Exhibits |
36 |
Signatures |
37 |
Risk Factors Summary
Our business is subject to numerous risks that you should carefully consider. These risks are more fully described in the section titled "Risk Factors" included in our Final Prospectus filed with the
· We have incurred significant losses since our inception, we expect to incur losses for the foreseeable future and we may never achieve or maintain profitability.
· We are highly dependent on a limited number of product offerings that require a substantial sales cycle and as a result we are prone to quarterly fluctuations in revenue. If we fail to maintain significant market acceptance in existing markets or fail to successfully increase our penetration in new and expanding markets, we will not generate expected revenue and our prospects may be harmed.
· We operate in a highly competitive market characterized by rapid technological change, evolving industry standards, changes in customer needs, emerging competition, new product introductions and strong price competition. Our success depends, in part, on our ability to maintain a competitive position in the development of technologies, enhancements and products for use by our customers.
· Our business currently depends significantly on research and development spending by biopharmaceutical companies and academic institutions, a reduction in which could limit demand for our products and adversely affect our business and operating results.
· We must develop new products, as well as enhancements to existing products, and adapt to rapid and significant technological change to remain competitive.
· If we cannot maintain and expand current partnerships and enter into new partnerships, including internationally, that generate marketed licensed products, our business could be adversely affected.
· The failure of our partners to meet their contractual obligations to us could adversely affect our business.
· Our partners may not achieve projected discovery and development milestones and other anticipated key events in the expected timelines or at all, or may discontinue some or all of their programs, which could have an adverse impact on our business.
· In recent periods, we have depended on a limited number of partners for our revenue, the loss of any of which could have an adverse impact on our business.
· We depend on continued supply of components and raw materials for our ExPERT instruments and PAs from third-party suppliers, and if shortages of these components or raw materials arise, we may not be able to secure enough components to build new products to meet customer demand or we may be forced to pay higher prices for these components. As such, we must also accurately forecast customer demand for our products and manage our inventory.
· Our FDA
· We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce, eliminate or abandon our commercialization efforts or product development programs.
· The COVID‑19 pandemic has had and could continue to have an adverse impact on our business, operations, and the markets and communities in which we, our partners and our customers operate.
· Our common stock is traded on two separate stock markets and investors seeking to take advantage of price differences between such markets may create unexpected volatility in our share price; in addition, investors may not be able to easily move shares for trading between such markets.
Part I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
2021 |
|
2020 |
||
|
|
|
(Unaudited) |
|
|
(Note 2) |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
37,423,200 |
|
$ |
18,755,200 |
Short-term investments, at amortized cost |
|
|
35,968,700 |
|
|
16,007,500 |
Accounts receivable, net |
|
|
5,719,200 |
|
|
5,171,900 |
Inventory, net |
|
|
4,169,500 |
|
|
4,315,800 |
Other current assets |
|
|
1,345,700 |
|
|
1,003,000 |
Total current assets |
|
|
84,626,300 |
|
|
45,253,400 |
|
|
|
|
|
|
|
Property and equipment, net |
|
|
5,472,200 |
|
|
4,546,200 |
Right of use asset - operating leases |
|
|
1,173,900 |
|
|
1,728,300 |
Right of use asset - finance leases |
|
|
170,700 |
|
|
218,300 |
Other assets |
|
|
1,704,100 |
|
|
33,900 |
Total assets |
|
$ |
93,147,200 |
|
$ |
51,780,100 |
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
644,700 |
|
$ |
890,200 |
Accrued expenses and other |
|
|
4,518,300 |
|
|
5,308,500 |
Operating lease liability, current |
|
|
616,500 |
|
|
572,600 |
Deferred revenue, current portion |
|
|
6,754,800 |
|
|
4,843,000 |
Total current liabilities |
|
|
12,534,300 |
|
|
11,614,300 |
|
|
|
|
|
|
|
Note payable, net of discount, and deferred fees |
|
|
- |
|
|
4,917,000 |
Operating lease liability, net of current portion |
|
|
606,700 |
|
|
1,234,600 |
Other liabilities |
|
|
1,185,000 |
|
|
788,800 |
Total liabilities |
|
|
14,326,000 |
|
|
18,554,700 |
|
|
|
|
|
|
|
Commitments and contingencies (Note 7) |
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
Common stock, |
|
|
847,200 |
|
|
773,800 |
Additional paid-in capital |
|
|
184,723,700 |
|
|
127,673,900 |
Accumulated deficit |
|
|
(106,749,700) |
|
|
(95,222,300) |
Total stockholders' equity |
|
|
78,821,200 |
|
|
33,225,400 |
Total liabilities and stockholders' equity |
|
$ |
93,147,200 |
|
$ |
51,780,100 |
See accompanying notes to unaudited condensed consolidated financial statements.
Unaudited Condensed Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
||||
Revenue |
|
$ |
7,108,100 |
|
$ |
5,150,400 |
|
$ |
13,602,900 |
|
$ |
10,892,400 |
|
Costs of goods sold |
|
|
784,500 |
|
|
466,300 |
|
|
1,477,600 |
|
|
1,125,300 |
|
Gross profit |
|
|
6,323,600 |
|
|
4,684,100 |
|
|
12,125,300 |
|
|
9,767,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,205,500 |
|
|
4,090,400 |
|
|
9,283,200 |
|
|
8,335,100 |
|
Sales and marketing |
|
|
2,912,900 |
|
|
1,843,900 |
|
|
5,702,000 |
|
|
3,894,000 |
|
General and administrative |
|
|
4,622,400 |
|
|
1,594,400 |
|
|
7,930,400 |
|
|
3,370,900 |
|
Total operating expenses |
|
|
10,740,800 |
|
|
7,528,700 |
|
|
22,915,600 |
|
|
15,600,000 |
|
Operating loss |
|
|
(4,417,200) |
|
|
(2,844,600) |
|
|
(10,790,300) |
|
|
(5,832,900) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense |
|
|
(13,200) |
|
|
(164,700) |
|
|
(755,500) |
|
|
(281,800) |
|
Interest income |
|
|
8,600 |
|
|
5,200 |
|
|
18,400 |
|
|
48,700 |
|
Total other income (expense) |
|
|
(4,600) |
|
|
(159,500) |
|
|
(737,100) |
|
|
(233,100) |
|
Provision for income taxes |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Net loss |
|
$ |
(4,421,800) |
|
$ |
(3,004,100) |
|
$ |
(11,527,400) |
|
$ |
(6,066,000) |
|
Basic and diluted net loss per share |
|
$ |
(0.05) |
|
$ |
(0.05) |
|
$ |
(0.14) |
|
$ |
(0.10) |
|
Weighted average shares outstanding, basic and diluted |
|
|
84,706,516 |
|
|
65,834,978 |
|
|
82,865,526 |
|
|
61,619,280 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
||
|
|
Common Stock |
|
Additional |
|
Accumulated |
|
Stockholders' |
||||||
|
|
Shares |
|
Amount |
|
|
|
Deficit |
|
Equity |
||||
Balance |
|
57,403,583 |
|
$ |
574,000 |
|
$ |
96,433,700 |
|
$ |
(83,405,900) |
|
$ |
13,601,800 |
Stock-based compensation expense |
|
- |
|
|
- |
|
|
547,600 |
|
|
- |
|
|
547,600 |
Net loss |
|
- |
|
|
- |
|
|
- |
|
|
(3,061,900) |
|
|
(3,061,900) |
Balance |
|
57,403,583 |
|
|
574,000 |
|
|
96,981,300 |
|
|
(86,467,800) |
|
|
11,087,500 |
Issuance of common stock |
|
19,181,423 |
|
|
191,900 |
|
|
28,375,300 |
|
|
- |
|
|
28,567,200 |
Stock-based compensation expense |
|
- |
|
|
- |
|
|
559,000 |
|
|
- |
|
|
559,000 |
Net loss |
|
- |
|
|
- |
|
|
- |
|
|
(3,004,100) |
|
|
(3,004,100) |
Balance |
|
76,585,006 |
|
$ |
765,900 |
|
$ |
125,915,600 |
|
$ |
(89,471,900) |
|
$ |
37,209,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
||
|
|
Common Stock |
|
Additional |
|
Accumulated |
|
Stockholders' |
||||||
|
|
Shares |
|
Amount |
|
|
|
Deficit |
|
Equity |
||||
Balance |
|
77,382,473 |
|
$ |
773,800 |
|
$ |
127,673,900 |
|
$ |
(95,222,300) |
|
$ |
33,225,400 |
Issuance of common stock |
|
5,740,000 |
|
|
57,400 |
|
|
51,751,500 |
|
|
- |
|
|
51,808,900 |
Stock-based compensation expense |
|
- |
|
|
- |
|
|
1,319,800 |
|
|
- |
|
|
1,319,800 |
Exercise of stock options |
|
1,567,086 |
|
|
15,700 |
|
|
2,021,400 |
|
|
- |
|
|
2,037,100 |
Net loss |
|
- |
|
|
- |
|
|
- |
|
|
(7,105,600) |
|
|
(7,105,600) |
Balance at |
|
84,689,559 |
|
|
846,900 |
|
|
182,766,600 |
|
|
(102,327,900) |
|
|
81,285,600 |
Stock-based compensation expense |
|
- |
|
|
- |
|
|
1,905,200 |
|
|
- |
|
|
1,905,200 |
Exercise of stock options |
|
29,786 |
|
|
300 |
|
|
51,900 |
|
|
- |
|
|
52,200 |
Net loss |
|
- |
|
|
- |
|
|
- |
|
|
(4,421,800) |
|
|
(4,421,800) |
Balance at |
|
84,719,345 |
|
$ |
847,200 |
|
$ |
184,723,700 |
|
$ |
(106,749,700) |
|
$ |
78,821,200 |
See accompanying notes to unaudited condensed consolidated financial statements.
Unaudited Condensed Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
Six Months Ended |
||||
|
|
2021 |
|
2020 |
||
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(11,527,400) |
|
$ |
(6,066,000) |
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization on property and equipment, net |
|
|
641,400 |
|
|
478,200 |
Net book value of consigned equipment sold |
|
|
13,900 |
|
|
12,000 |
Loss on disposal of fixed assets |
|
|
19,800 |
|
|
51,300 |
Fair value adjustment of liability classified warrant |
|
|
358,200 |
|
|
- |
Stock-based compensation |
|
|
3,225,000 |
|
|
1,106,600 |
Bad debt (recovery) expense |
|
|
- |
|
|
(117,200) |
Amortization of discounts on short-term investments |
|
|
1,900 |
|
|
(1,100) |
Noncash interest expense |
|
|
5,400 |
|
|
10,800 |
|
|
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
(547,300) |
|
|
(385,600) |
Inventory |
|
|
(182,300) |
|
|
(608,900) |
Other current assets |
|
|
(342,700) |
|
|
9,700 |
Right of use asset - operating leases |
|
|
554,400 |
|
|
258,200 |
Right of use asset - finance lease |
|
|
47,600 |
|
|
35,700 |
Other assets |
|
|
(1,670,200) |
|
|
(100,000) |
Accounts payable, accrued expenses and other |
|
|
(992,400) |
|
|
(2,339,200) |
Operating lease liability |
|
|
(584,000) |
|
|
(248,800) |
Deferred revenue |
|
|
1,911,800 |
|
|
1,879,000 |
Other liabilities |
|
|
38,000 |
|
|
(14,300) |
Net cash used in operating activities |
|
|
(9,028,900) |
|
|
(6,039,600) |
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
Purchases of short-term investments |
|
|
(35,963,100) |
|
|
(1,001,100) |
Maturities of short-term investments |
|
|
16,000,000 |
|
|
2,500,000 |
Purchases of property and equipment |
|
|
(1,271,100) |
|
|
(1,049,900) |
Proceeds from sale of equipment |
|
|
4,600 |
|
|
- |
Net cash (used in) provided by investing activities |
|
|
(21,229,600) |
|
|
449,000 |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
Net proceeds from issuance of common stock |
|
|
51,808,900 |
|
|
28,567,200 |
Borrowings under notes payable |
|
|
- |
|
|
1,440,000 |
Principal payments on notes payable |
|
|
(4,922,400) |
|
|
(1,440,000) |
Proceeds from exercise of stock options |
|
|
2,089,300 |
|
|
- |
Principal payments on finance leases |
|
|
(49,300) |
|
|
(15,700) |
Net cash provided by financing activities |
|
|
48,926,500 |
|
|
28,551,500 |
Net increase in cash and cash equivalents |
|
|
18,668,000 |
|
|
22,960,900 |
Cash and cash equivalents, beginning of period |
|
|
18,755,200 |
|
|
15,210,800 |
Cash and cash equivalents, end of period |
|
$ |
37,423,200 |
|
$ |
38,171,700 |
|
|
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
419,200 |
|
$ |
210,700 |
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
Property and equipment purchases included in accounts payable |
|
$ |
6,000 |
|
$ |
159,000 |
Lease liability reduction due to operating lease modification |
|
$ |
304,600 |
|
$ |
- |
See accompanying notes to unaudited condensed consolidated financial statements.
1. Organization and Description of Business
The COVID‑19 pandemic has disrupted economic markets and the economic impact, duration and spread of related effects is uncertain at this time and difficult to predict. As a result, it is not possible to ascertain the overall future impact of COVID‑19 on the Company's business and, depending upon the extent and severity of such effects, including, but not limited to potential slowdowns in customer operations, extension of sales cycles, shrinkage in customer capital budgets or delays in customers' clinical trials, the pandemic could have a material adverse effect on the Company's business, results of operations, financial condition and cash flows. In 2020, the Company made adjustments to its operating, sales and marketing practices to mitigate the effects of COVID‑19 restrictions which reduced planned spending, particularly on travel and marketing expenditures. In addition, COVID‑19 restrictions may have delayed or slowed the research activities of some existing and prospective customers. It is not possible to quantify the impact of COVID‑19 on the Company's revenues and expenses in the first half of 2021or its expected impact on future periods.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with accounting principles generally accepted in
Significant Accounting Policies
The Company's significant accounting policies are disclosed in the footnotes to its audited consolidated financial statements for the year ended December 31, 2020 included in the Final Prospectus and have not materially changed during the six months ended June 30, 2021, except as noted below.
Concentration of Significant Customers
Significant customers are those that accounted for 10% or more of the Company's total revenue for the period or accounts receivable as the end of a reporting period. During the three and six months ended June 30, 2021, one customer represented 17% and 18% of revenue, respectively. During the three months ended June 30, 2020, one customer represented 23% of revenue, and during the six months ended June 30, 2020, two customers represented 15% and 12% of revenue, respectively. As of June 30, 2021, one customer accounted for 22% of accounts receivable. No customer accounted for over 10% of accounts receivable at December 31, 2020.
Certain components included in the Company's products are obtained from a single source or a limited group of suppliers. During the three and six months ended June 30, 2021, the Company purchased approximately 56% and 48% of its inventory from three and two suppliers, respectively. During the three and six months ended June 30, 2020, the Company purchased approximately 60% and 57% of its inventory from three suppliers and one supplier, respectively. As of June 30, 2021 and December 31, 2020, amounts payable to these suppliers totaled 11% and 31% of total accounts payable, respectively.
Foreign Currency
The Company's functional currency is the US dollar; transactions denominated in foreign currencies are subject to currency risk. The Company recognized $3,600 in foreign currency transaction gains and $7,600 in foreign currency transaction losses for the three months ended June 30, 2021 and 2020, respectively. The Company recognized $23,400 and $16,700 in foreign currency transaction gains for the six months ended June 30, 2021 and 2020, respectively.
Cash, Cash Equivalents and Short-term Investments
The following table summarizes the Company's cash equivalents and short-term investments at June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
||
|
|
|
|
Amortized |
|
unrecognized |
|
unrecognized |
|
Aggregate |
||||
Description |
|
Classification |
|
cost |
|
holding gains |
|
holding losses |
|
fair value |
||||
Money market funds |
|
Cash equivalents |
|
$ |
5,270,300 |
|
$ |
- |
|
$ |
- |
|
$ |
5,270,300 |
Corporate Debt |
|
Cash equivalents |
|
|
1,001,500 |
|
|
- |
|
|
(100) |
|
|
1,001,400 |
Commercial Paper |
|
Cash equivalent |
|
|
27,996,800 |
|
|
1,400 |
|
|
- |
|
|
27,998,200 |
Corporate Debt |
|
Short-term investments |
|
|
35,968,700 |
|
|
21,600 |
|
|
- |
|
|
35,990,300 |
Total Investments |
|
|
|
$ |
70,237,300 |
|
$ |
23,000 |
|
$ |
(100) |
|
$ |
70,260,200 |
The following table summarizes the Company's cash equivalents and short-term investments at December 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
||
|
|
|
|
Amortized |
|
unrecognized |
|
unrecognized |
|
Aggregate |
||||
Description |
|
Classification |
|
cost |
|
holding gains |
|
holding losses |
|
fair value |
||||
Money market funds |
|
Cash equivalents |
|
$ |
8,702,200 |
|
$ |
- |
|
$ |
- |
|
$ |
8,702,200 |
Commercial Paper |
|
Cash equivalents |
|
|
6,523,500 |
|
|
- |
|
|
- |
|
|
6,523,500 |
Commercial Paper |
|
Short‑term investments |
|
|
13,996,800 |
|
|
1,800 |
|
|
- |
|
|
13,998,600 |
Corporate Debt |
|
Short‑term investments |
|
|
2,010,700 |
|
|
- |
|
|
(100) |
|
|
2,010,600 |
Total Investments |
|
|
|
$ |
31,233,200 |
|
$ |
1,800 |
|
$ |
(100) |
|
$ |
31,234,900 |
At times the Company's cash balances may exceed federally insured limits and cash may also be deposited in foreign bank accounts that are not covered by federal deposit insurance. The Company does not believe that this results in any significant credit risk.
Inventory
Inventory is carried at the lower of cost or net realizable value. Inventory consisted of the following at:
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
||
|
|
2021 |
|
2020 |
|
||
Raw materials inventory |
|
$ |
1,859,600 |
|
$ |
1,771,300 |
|
Finished goods inventory |
|
|
2,309,900 |
|
|
2,544,500 |
|
Total inventory |
|
$ |
4,169,500 |
|
$ |
4,315,800 |
|
The Company determined no allowance for obsolescence was necessary at June 30, 2021 or December 31, 2020.
Accounts Receivable
Accounts receivables are reduced by an allowance for doubtful accounts, if needed. The Company determined no allowance was necessary at June 30, 2021 or December 31, 2020.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method. Leasehold improvements are amortized over the shorter of the estimated lease term or useful life.
Property and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
||
|
|
2021 |
|
2020 |
|
||
Furniture and equipment |
|
$ |
3,696,400 |
|
$ |
3,492,900 |
|
Instruments |
|
|
1,755,600 |
|
|
1,424,600 |
|
Leasehold improvements |
|
|
641,400 |
|
|
641,400 |
|
Internal-use software under development |
|
|
980,200 |
|
|
- |
|
Internal-use software |
|
|
1,999,300 |
|
|
1,963,000 |
|
Accumulated depreciation and amortization |
|
|
(3,600,700) |
|
|
(2,975,700) |
|
Property and equipment, net |
|
$ |
5,472,200 |
|
$ |
4,546,200 |
|
For the six months ended June 30, 2021, the Company transferred $328,600 of instruments previously classified as inventory to property and equipment leased to customers. For the six months ended June 30, 2020, the Company transferred $154,000 of instruments previously classified as inventory to property and equipment leased to customers.
For the three and six months ended June 30, 2021, the Company incurred depreciation and amortization expense of $325,000 and $641,400, respectively. For the three and six months ended June 30, 2020, the Company incurred depreciation and amortization expense of $256,500 and $478,200, respectively.
In the three and six months ended June 30, 2020, the Company capitalized $5,700 and $8,200, respectively, of interest expense related to capitalized software development projects. No interest expense was capitalized in the three and six months ended June 30, 2021.
Deferred Offering Costs
The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs (non-current) until such financings are consummated or determined not to be probable of consummation. After consummation of the equity financing, these costs are recorded in stockholders' equity as a reduction of proceeds received as a result of the offering. If the equity financing is no longer considered probable of being consummated, all deferred offering costs will be charged to operating expenses in the consolidated statement of operations at such time.
As of June 30, 2021 and December 31, 2020, $1,384,500 and $0, respectively, of deferred offering costs were reported as other assets in the condensed consolidated balance sheets.
Leases
In transactions where the Company is the lessee, at the inception of a contract, the Company determines if the arrangement is, or contains, a lease. See Note 7 for additional details over leases where the Company is the lessee.
All transactions in which the Company is the lessor are short-term (one year or less) and have been classified as operating leases. All leases require upfront payments covering the full period of the lease and thus, there are no future payments expected to be received from existing leases. See Note 3 for details over revenue recognition related to lease agreements.
Loss Per Share
Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period.
For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method.
For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares excluded from the computation of diluted loss per share, consisting of shares underlying stock options and stock purchase warrants, was 12.2 million and 12.4 million for the three and six months ended June 30, 2021 and 2020, respectively.
Recent Accounting Pronouncements
Recently Adopted
On January 1, 2021, the Company adopted new guidance addressing income taxes, which is intended to simplify various aspects related to the accounting for income taxes. The guidance removes certain exceptions to the general principles in Accounting Standards Codification ("ASC") 740, Income Taxes, and also clarifies and amends existing guidance to improve consistent application. The adoption did not have a material effect on the Company's condensed consolidated interim financial statements.
New Accounting Pronouncements Not Yet Adopted
In June 2016, the
The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its results of operations, financial position, or cash flows.
3. Revenue
Revenue is principally from the sale of instruments and processing assemblies, and extended warranties and the lease of instruments, which leases also include customer-specific milestone payments. In some arrangements, products and services have been sold together representing distinct performance obligations. In these arrangements the Company allocates the sale price to the various performance obligations in the arrangement on a relative selling price basis. Under this basis, the Company determines the estimated selling price of each performance obligation in a manner that is consistent with that used to determine the price to sell the deliverable on a standalone basis.
Revenue is recognized at the time control is transferred to the customer and the performance obligation is satisfied. Revenue from the sale of instruments and processing assemblies is generally recognized at the time of shipment to the customer, provided that no significant vendor obligations remain and collectability is reasonably assured. Revenue from equipment leases is recognized ratably over the contractual term of the lease agreement and when specific milestones are achieved by a customer. Licensing fee revenue is recognized ratably over the license period. Revenue from fees for research services is recognized when services have been provided.
Disaggregation of Revenue
The following table depicts the disaggregation of revenue by type of contract:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2021 |
|
Six months ended June 30, 2021 |
|
||||||||||||||
|
|
Revenue from |
|
Revenue |
|
|
|
|
Revenue from |
|
Revenue |
|
|
|
|
||||
|
|
Contracts |
|
from |
|
|
|
Contracts |
|
from |
|
|
|
||||||
|
|
with |
|
Lease |
|
Total |
|
with |
|
Lease |
|
Total |
|
||||||
|
|
Customers |
|
Elements |
|
Revenue |
|
Customers |
|
Elements |
|
Revenue |
|
||||||
Product Sales |
|
$ |
4,041,600 |
|
$ |
- |
|
$ |
4,041,600 |
|
$ |
8,117,400 |
|
$ |
- |
|
$ |
8,117,400 |
|
Lease Elements |
|
|
- |
|
|
2,889,700 |
|
|
2,889,700 |
|
|
- |
|
|
5,145,600 |
|
|
5,145,600 |
|
Other |
|
|
176,800 |
|
|
- |
|
|
176,800 |
|
|
339,900 |
|
|
- |
|
|
339,900 |
|
Total |
|
$ |
4,218,400 |
|
$ |
2,889,700 |
|
$ |
7,108,100 |
|
$ |
8,457,300 |
|
$ |
5,145,600 |
|
$ |
13,602,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2020 |
|
Six months ended June 30, 2020 |
|
||||||||||||||
|
|
Revenue from |
|
Revenue |
|
|
|
|
Revenue from |
|
Revenue |
|
|
|
|
||||
|
|
Contracts |
|
from |
|
|
|
Contracts |
|
from |
|
|
|
||||||
|
|
with |
|
Lease |
|
Total |
|
with |
|
Lease |
|
Total |
|
||||||
|
|
Customers |
|
Elements |
|
Revenue |
|
Customers |
|
Elements |
|
Revenue |
|
||||||
Product Sales |
|
$ |
2,244,300 |
|
$ |
- |
|
$ |
2,244,300 |
|
$ |
5,439,500 |
|
$ |
- |
|
$ |
5,439,500 |
|
Lease Elements |
|
|
- |
|
|
2,824,100 |
|
|
2,824,100 |
|
|
- |
|
|
5,252,100 |
|
|
5,252,100 |
|
Other |
|
|
82,000 |
|
|
- |
|
|
82,000 |
|
|
200,800 |
|
|
- |
|
|
200,800 |
|
Total |
|
$ |
2,326,300 |
|
$ |
2,824,100 |
|
$ |
5,150,400 |
|
$ |
5,640,300 |
|
$ |
5,252,100 |
|
$ |
10,892,400 |
|
Additional Disclosures Relating to Revenue from Contracts with Customers
Deferred revenue represents payments received for performance obligations not yet satisfied and is presented as current or long-term in the accompanying condensed consolidated balance sheets based on the expected timing and satisfaction of the underlying goods or services. Deferred revenue was $7.1 million and $5.0 million as of June 30, 2021 and December 31, 2020, respectively. During the three and six months ended June 30, 2021, the Company recognized $1.5 million and $3.5 million, respectively, and during the three and six months ended June 30, 2020, $1.0 million and $2.5 million, respectively, of revenue that was included in deferred revenue at the beginning of such periods.
Remaining contract consideration for which revenue has not been recognized due to unsatisfied performance obligations with a duration greater than one year at June 30, 2021 was $366,800, of which the Company expects to recognize $71,200 in one year or less, $72,000 in one to two years, $67,000 in two to three years, and $156,600 thereafter.
For the three and six months ended June 30, 2021 and 2020, the Company did not incur, and therefore did not defer, any material incremental costs to obtain contracts or costs to fulfill contracts.
4. Debt
In November 2019, the Company entered into a new credit facility with MidCap Financial SBIC, LP ("MidCap"). The credit facility provided for a $5 million term loan maturing on November 1, 2024. The term loan provided for (i) an interest rate of one-month Libor plus 6.5% with a 1.5% Libor floor, (ii) monthly interest payments, (iii) 30 monthly principal payments of $166,700 beginning in June 2022 and (iv) a 3% final payment fee. The Company used the proceeds from the credit facility for general operating purposes. The debt was collateralized by substantially all assets of the Company. At December 31, 2020, the term loan had an outstanding principal balance of $5.0 million and $83,000 of unamortized debt discount. In March 2021, the Company repaid the MidCap loan in full. The Company incurred fees of $260,000 associated with early repayment of the loan. The unamortized debt discounts and fees were expensed and recorded as interest expense.
In April 2020, the Company received a loan from
5. Stockholders' Equity
Common Stock
During the first quarter of 2021, the Company completed an equity capital raise issuing 5,740,000 shares of its common stock at a price of ₤7.00 (or approximately $9.64) per share. The transaction generated gross proceeds of ₤40.2 million (or $55.3 million). In conjunction with the transaction, the Company incurred costs of $3.5 million which resulted in the Company receiving net proceeds of $51.8 million.
Warrant
In connection with the November 2019 credit facility (see Note 4), the Company issued the lender a warrant to purchase 71,168 shares of common stock at an exercise price of £1.09081 per share. Through June 30, 2021, the warrant is exercisable at any time through the tenth anniversary of issuance. The warrant was classified as a liability, as its strike price was in a currency other than the Company's functional currency. The warrant was recorded at fair value at the end of each reporting period with changes from the prior balance sheet date recorded on the condensed consolidated statements of operations (see Note 6). In August 2021, MidCap exercised the warrant in full (see Note 8).
Stock Options
The Company adopted the
At December 31, 2020 and June 30, 2021, there were 4,175,737 and 4,090,810 shares available to be issued under the Plan, respectively.
The weighted-average fair value of the options granted during the three months ended June 30, 2021 and 2020 was estimated to be $7.22 and $1.09, respectively. The weighted-average fair value of the options granted during the six months ended June 30, 2021 and 2020 was estimated to be $7.32 and $0.87, respectively.
The value of an option award is recognized as expense on a straight-line basis over the requisite service period. At June 30, 2021, total unrecognized compensation expense was $20,211,400, which will be recognized over the next 3.2 years.
The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
||||
General and administrative |
|
$ |
1,169,600 |
|
$ |
265,900 |
|
$ |
1,911,300 |
|
$ |
519,900 |
|
Sales and marketing |
|
|
352,400 |
|
|
112,000 |
|
|
621,600 |
|
|
218,000 |
|
Research and development |
|
|
383,200 |
|
|
181,100 |
|
|
692,100 |
|
|
368,700 |
|
Total |
|
$ |
1,905,200 |
|
$ |
559,000 |
|
$ |
3,225,000 |
|
$ |
1,106,600 |
|
6. Fair Value
The Company's condensed consolidated balance sheets include various financial instruments (primarily cash and cash equivalents, accounts receivable and accounts payable) that are carried at cost, which approximates fair value due to the short-term nature of the instruments. The Company's short-term investments are carried at amortized cost (see Note 2 for fair values of short-term investments). Notes payable are reflective of fair value based on market comparable instruments with similar terms.
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company had an outstanding warrant accounted for as a liability and measured at fair value on a recurring basis, using Level 3 inputs. The following table identifies the carrying amount of this warrant at June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
||||
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Liability classified warrant |
|
$ |
- |
|
$ |
- |
|
$ |
799,400 |
|
$ |
799,400 |
Total at June 30, 2021 |
|
$ |
- |
|
$ |
- |
|
$ |
799,400 |
|
$ |
799,400 |
The following table identifies the carrying amount of this warrant at December 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
||||
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Liability classified warrant |
|
$ |
- |
|
$ |
- |
|
$ |
441,200 |
|
$ |
441,200 |
Total at December 31, 2020 |
|
$ |
- |
|
$ |
- |
|
$ |
441,200 |
|
$ |
441,200 |
The following table presents the activity for those items measured at fair value on a recurring basis using Level 3 inputs for the three and six months ended June 30, 2021 and 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark-to-market liabilities - warrant |
||||||||||
|
|
Three Months Ended |
|
Six Months Ended |
||||||||
|
|
June 30, |
|
June 30, |
||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||
Balance, beginning of period |
|
$ |
789,100 |
|
$ |
74,500 |
|
$ |
441,200 |
|
$ |
74,700 |
Change in fair value |
|
|
10,300 |
|
|
51,500 |
|
|
358,200 |
|
|
51,300 |
Balance, end of period |
|
$ |
799,400 |
|
$ |
126,000 |
|
$ |
799,400 |
|
$ |
126,000 |
The gains and losses resulting from the changes in the fair value of the warrant liability are classified as other income or expense in the accompanying condensed consolidated statements of operations. The fair value of the Common Stock purchase warrants is determined based on the Black-Scholes option pricing model or other option pricing models as appropriate and included the use of unobservable inputs such as the expected term, anticipated volatility and expected dividends. Changes in any of the assumptions related to such unobservable inputs may change the fair value; increases in expected term, anticipated volatility and expected dividends generally result in increases in fair value, while decreases in these unobservable inputs generally result in decreases in fair value.
The Company has no other financial assets or liabilities measured at fair value on a recurring basis.
Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
Short-term investments carried at amortized cost are measured at fair value on a non-recurring basis when they are deemed to be impaired on an other-than-temporary basis. No fair value impairment was recognized during the three and six months ended June 30, 2021 and 2020.
Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis.
Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
The Company measures its long-lived assets, including property and equipment, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be impaired. No fair value impairment was recognized during the three and six months ended June 30, 2021 and 2020.
7. Commitments and Contingencies
Operating Leases
The Company is a party to various leases for office and laboratory space. A member of the Company's Board of Directors is the CEO and Board member of the lessor of certain of these leases for which the rent payments totaled $159,600 and $155,800 in the three months ended June 30, 2021 and 2020, respectively, and $318,300 and $310,500 in the six months ended June 30, 2021 and 2020, respectively.
At June 30, 2021, the Company had a $1,173,900 right of use (ROU) lease asset, a $616,500 short-term lease liability and a $606,700 long-term lease liability related to its operating leases. At December 31, 2020, the Company had a $1,728,300 ROU asset, a $572,600 short-term lease liability and a $1,234,600 long-term lease liability related to its operating leases.
At June 30, 2021 and December 31, 2020, the weighted average remaining lease term for the Company's operating leases was 2.1 years and 2.8 years, respectively.
On May 27, 2021, the Company entered into an operating lease for new office and manufacturing space. The lease for the new space consists of three phases, with Phase 1 estimated to commence in October 2021 which is subject to revision, and the lease of all phases is estimated to expire on June 30, 2035. Both the Company and the landlord have a one-time right to terminate a portion of Phase 3 of the lease during a defined time window. The Company will design and construct the leasehold improvements with the approval of the landlord. The landlord will reimburse the Company for the costs of property improvements up to amounts specified in the lease. The total incremental non-cancellable lease payments under the new lease agreements are approximately $24.5 million over the lease term.
Finance Leases
At June 30, 2021, the Company had a $170,700 ROU asset, a $102,800 short-term lease liability included in "Accrued expenses and other" and a $90,100 long-term lease liability included in "Other liabilities" related to its finance lease.
At December 31, 2020, the Company had a $218,300 ROU asset, a $100,000 short-term lease liability included in "Accrued expenses and other" and a $142,200 long-term lease liability included in "Other liabilities" related to its finance lease.
All Leases
Lease costs for the three and six months ended June 30, 2021 and 2020 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
||||||||
|
|
June 30, |
|
June 30, |
|
||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
||||
Finance lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of ROU asset |
|
$ |
23,800 |
|
$ |
23,800 |
|
$ |
47,600 |
|
$ |
35,700 |
|
Interest on expense |
|
|
2,900 |
|
|
4,200 |
|
|
6,100 |
|
|
6,900 |
|
Operating lease cost |
|
|
174,200 |
|
|
170,100 |
|
|
346,900 |
|
|
337,200 |
|
Short-term lease cost |
|
|
10,000 |
|
|
- |
|
|
18,900 |
|
|
- |
|
Variable lease cost |
|
|
75,600 |
|
|
65,700 |
|
|
151,200 |
|
|
141,500 |
|
Total lease cost |
|
$ |
286,500 |
|
$ |
263,800 |
|
$ |
570,700 |
|
$ |
521,300 |
|
As of June 30, 2021, maturities of lease liabilities that have commenced prior to June 30, 2021 were as follows:
|
|
|
|
|
|
|
|
|
Operating Leases |
|
Finance Leases |
||
|
|
|
|
|
||
Remainder of 2021 |
|
$ |
360,300 |
|
$ |
55,400 |
2022 |
|
|
579,200 |
|
|
110,800 |
2023 |
|
|
405,000 |
|
|
36,900 |
Total lease payments |
|
|
1,344,500 |
|
|
203,100 |
Discount factor |
|
|
(121,300) |
|
|
(10,300) |
Present value of lease liabilities |
|
$ |
1,223,200 |
|
$ |
192,800 |
8. Subsequent Events
Initial Public Offering
The Company's registration statement on Form S‑1 related to its initial public offering of common stock in
Warrant Exercise
In a cashless settlement on August 11, 2021, MidCap exercised its warrant (see Note 5), in whole, for 64,603 shares of common stock.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10‑Q, our audited consolidated financial statements and related notes for the year ended December 31, 2020, included in our final prospectus dated July 29, 2021 (the "Final Prospectus"), as filed with the Securities and Exchange Commission (the "
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10‑Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements about us and our industry that involve substantial risks, uncertainties, and assumptions, including those described in "Risk Factors Summary" and elsewhere in this report. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
· our expected future growth and the success of our business model;
· the potential payments we may receive pursuant to our Strategic Platform Licenses ("SPLs");
· the size and growth potential of the markets for our products, and our ability to serve those markets, increase our market share and achieve and maintain industry leadership;
· the rate and degree of market acceptance of our products within the cell engineering market;
· the expected future growth of our manufacturing capabilities and sales, support and marketing capabilities;
· our ability to expand our customer base and enter into additional SPLs;
· our ability to accurately forecast and manufacture appropriate quantities of our products to meet commercial demand;
· our expectations regarding development of the cell therapy market, including projected growth in adoption of non-viral delivery approaches and gene editing manipulation technologies;
· our ability to maintain our FDA
· our research and development for any future products, including our intention to introduce new instruments and processing assemblies and move into new applications;
· the development, regulatory approval, and commercialization of competing products and our ability to compete with the companies that develop and sell such products;
· our ability to retain and hire senior management and key personnel;
· regulatory developments in
· our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;
· our ability to develop and maintain our corporate infrastructure, including our internal controls;
· our financial performance and capital requirements;
· our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others; and
· our use of available capital resources.
You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in the section titled "Risk Factors Summary" in this report and under the caption "Risk Factors" and elsewhere in the Final Prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this report. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10‑Q. And while we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
The forward-looking statements made in this Quarterly Report on Form 10‑Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report to reflect events or circumstances after the date of this Quarterly Report or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.
You should read this Quarterly Report and the documents that we file with the
Overview
We are a leading commercial cell engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization. Over the past twenty years, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering through the delivery of molecules into a wide variety of cells. Electroporation is a method of transfection, or the process of deliberately introducing molecules into cells, that involves applying an electric field to temporarily increase the permeability of the cell membrane. This precisely controlled increase in permeability allows the intracellular delivery of molecules, such as genetic material and proteins, that would not normally be able to cross the cell membrane as easily.
Our ExPERT platform, which is based on our Flow Electroporation technology, has been designed to address this rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: three instruments, the ATx, STx and GTx; our portfolio of proprietary single-use processing assemblies, or disposables; and software protocols. We have garnered meaningful expertise in cell engineering via our internal research and development efforts as well as our customer-focused commercial approach, which includes a growing application scientist team. The platform is also supported by a robust intellectual property portfolio with 50 granted
From leading commercial cell therapy drug developers and top biopharmaceutical companies to top academic and government research institutions, including the
Since our inception, we have incurred significant operating losses. Our ability to generate revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products. We generated revenue of $13.6 million and incurred a net loss of $11.5 million for the six months ended June 30, 2021. As of June 30, 2021, we had an accumulated deficit of $106.7 million. We expect to continue to incur net losses as we focus on growing commercial sales of our products in both
Impact of COVID‑19 on Our Business
We continue to closely monitor the impact of the novel coronavirus ("COVID‑19") pandemic on our business and the geographic regions where we operate. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.
Impacts to our business as a result of COVID‑19 have included disruptions to our manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts, decreased productivity and delayed availability of materials or components, limitations on our employees' and customers' ability to travel, and delays in product installations, demonstrations, trainings or shipments to and from affected countries and within
We do not yet know the full impact that the COVID‑19 pandemic may have on our business and cannot guarantee that it will not be materially negative. Although we continue to monitor the situation and may adjust our policies as more information and public health guidance become available, the ongoing effects of the COVID‑19 pandemic and/or the precautionary measures that we or our customers have implemented or may adopt may create operational and other challenges, any of which could harm our business and results of operations.
Recent Developments
Our registration statement on Form S‑1 related to our initial public offering of common stock in
We have also continued to enter into Strategic Platform License ("SPL") agreements with our cell therapy customers. These agreements are discussed in more detail in "Results of Operations" below and provide us with revenue from instrument technology access fees and disposables as well as downstream economics on our partners' programs (both pre- and post-commercial). In the first six months of 2021, we signed SPL agreements with Myeloid Therapeutics and Celularity, Inc., and signed a third agreement with Sana Biotechnology in the third quarter of this year. We continue to grow our SPL pipeline and, while the specific timing of any agreement is uncertain, we believe we have several potential opportunities to sign SPL agreements in the coming months.
We recognized $0.5 million and $1.8 million in milestone revenue in the first six months of 2021 and 2020, respectively. Although there is uncertainty around the timing and realization of milestones, as they are dependent on the regulatory activities and clinical success of our partners, we are encouraged by the potential for meaningful milestone revenue over the next 12 to 18 months as our partners progress through the clinic towards pivotal trials.
Results of Operations
Comparison of the Three Months Ended June 30, 2021 and 2020
The following table sets forth our results of operations for the periods presented:
|
|
|
|
|
|
|
Three Months Ended |
||
|
|
June 30, |
||
|
|
2021 |
|
2020 |
|
|
(in thousands) |
||
|
|
|
|
|
Total revenue |
$ |
7,108 |
$ |
5,150 |
Cost of goods sold |
|
785 |
|
466 |
Gross profit |
|
6,323 |
|
4,684 |
Operating expense |
|
|
|
|
Research and development |
|
3,206 |
|
4,090 |
Sales and marketing |
|
2,913 |
|
1,844 |
General and administrative |
|
4,622 |
|
1,594 |
Total operating expense |
|
10,741 |
|
7,528 |
Operating loss |
|
(4,418) |
|
(2,844) |
Other income (expense) |
|
|
|
|
Interest and other expense |
|
(13) |
|
(165) |
Interest and other income |
|
9 |
|
5 |
Total other income (expense) |
|
(4) |
|
(160) |
Net loss |
$ |
(4,422) |
$ |
(3,004) |
Revenue
We generate revenue principally from the sale of instruments and single-use processing assemblies ("PAs") and buffer, and from the lease of instruments to our customers. In addition, our SPLs include clinical progress milestones and sales-based payments to us which may also provide material revenues.
In order to evaluate how our sales are trending across key markets, as well as the contribution of program economics from our SPLs, we separately analyze revenue derived from our cell therapy customers and drug discovery customers, as well as the performance-based milestone revenues we recognize under our SPLs. Cell therapy revenues include primarily revenue from instruments sold, annual license fees for instruments under lease, and sales of our proprietary disposables. Drug discovery revenue includes primarily revenue from instruments sold, sales of our proprietary disposables and, occasionally, instruments leased. Program related revenues includes clinical progress milestone and sales-based revenues derived from SPL agreements. To date, all Program-related revenue has consisted entirely of pre-commercial milestone revenue.
The following table provides details regarding the sources of our revenue for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
||||
|
|
June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Cell therapy |
|
$ |
4,766 |
|
$ |
2,999 |
|
$ |
1,767 |
|
59% |
|
Drug discovery |
|
|
1,838 |
|
|
1,150 |
|
|
689 |
|
60% |
|
Program-related |
|
|
504 |
|
|
1,002 |
|
|
(498) |
|
(50%) |
|
Total Revenue |
|
$ |
7,108 |
|
$ |
5,150 |
|
$ |
1,958 |
|
38% |
|
Total revenue for the three months ended June 30, 2021 was $7.1 million, an increase of $2.0 million, or 38%, compared to revenue of $5.2 million during the three months ended June 30, 2020.
Our overall increase in revenue was primarily driven by growth in sales and licenses of instruments and sales of disposables, partially offset by a decrease in program-related revenue. In the cell therapy market, instrument sales and licenses of instruments increased by $0.8 million which was primarily due to continued high levels of capital invested in companies operating in our target markets, while disposable sales increased by $0.9 million, as a result of the continued progression of our cell therapy partners' clinical development programs. In the drug discovery market, the $0.7 million increase was primarily driven by a growth resurgence lead by the sales of newly introduced multi-well processing assemblies. The $0.5 million decrease in program-related revenues resulted from expected variability given the small number of individual triggering events which currently generate this portion of revenue. We expect program-related revenue to experience variability for some time, although we anticipate that it may moderate as the volume of SPLs and associated milestones grows.
We expect total revenue to increase over time as our markets grow and we are able to secure additional instrument and disposable sales and as the percentage of our installed base that are under cell therapy license agreements increases. We expect revenue from instruments licensed to cell therapy customers to continue to grow as those customers move their existing drug development programs into later-stage clinical trials and advance their preclinical pipeline programs into clinical development. In addition, we expect new customers to emerge and contribute to these revenues, particularly given the underlying growth in the cell therapy pipeline among companies in this market, continued availability of capital to support such companies, and in particular the switch by some of these cell therapy companies away from viral to non-viral approaches. We expect, however, that our revenue will fluctuate from period to period due to the timing of securing product sales and licenses, the inherently uncertain nature of the timing of our partner's milestone achievements and our dependence on the program decisions of our partners.
Costs of Goods Sold and Gross Profit
Costs of goods sold primarily consists of costs for instrument and processing assembly components, contract manufacturer costs, salaries, overhead and other direct costs related to sales recognized as revenue in the period. Costs of goods sold associated with instrument lease revenue consists of leased equipment depreciation. Gross profit is calculated as revenue less costs of goods sold. Gross profit margin is gross profit expressed as a percentage of revenue.
Our gross profit in future periods will depend on a variety of factors, including sales mix among instruments, disposables and milestones, the specific mix among types of instruments or disposables, the proportion of revenues associated with instrument leases as opposed to sales, changes in the costs to produce our various products, the launch of new products or changes in existing products, our cost structure for manufacturing including changes in production volumes, and the pricing of our products which may be impacted by market conditions.
We have generated overall gross margins of approximately 89% over the past several years, including during the three and six months ended June 30, 2021 and 2020. Our margins depend on the revenue mix from instruments, PAs and potential milestones under SPLs. We price our instruments at a premium given what we believe to be the broad benefits of our platform, and the limited availability of alternative, clinically validated non-viral delivery approaches. However, the market for non-viral delivery is highly competitive, and introduction of a GMP-grade platform by a competitor that delivers similar performance across a similar diversity of cell types could negatively impact our business and lead to increased price pressure that negatively impacts our gross margins.
In addition, part of our growth strategy is to expand into new regional markets, which could require the use of distributors and/or our participation in more competitive environments, which could impact our ability to price our instruments at a premium and could negatively impact our ability to enter into SPLs on terms similar to those currently in effect.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
785 |
|
$ |
466 |
|
$ |
319 |
|
68% |
|
Gross profit |
|
$ |
6,324 |
|
$ |
4,684 |
|
$ |
1,640 |
|
35% |
|
Gross margin |
|
|
89% |
|
|
90% |
|
|
|
|
|
|
Costs of goods sold increased by $0.3 million, or 68%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The increase was primarily driven by higher sales of instruments and disposables.
Gross profit increased by $1.6 million, or 35%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The increase was primarily driven by increased revenue from instrument and disposable sales and licensed instruments.
We expect that our costs of goods sold will generally increase or decrease as our instrument and disposables revenue increases or decreases. We expect our gross margin to benefit from realization of the economics from our SPL agreements, to the extent that such milestones grow to be a significant proportion of overall revenues, as there are no costs of goods sold associated with such revenue. However, realization and timing of these potential milestone revenues is uncertain.
Operating Expenses
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,206 |
|
$ |
4,090 |
|
|
($ 885) |
|
(22%) |
|
Research and development expenses consist primarily of costs incurred for our research activities related to advancing our technology and development of applications for our technology, including research into specific applications and associated data development, process development, product development (e.g. development of instruments and disposables, including hardware and software engineering) and design and other costs not directly charged to inventory or costs of goods sold.
These expenses principally include employee-related costs, such as salaries, benefits, incentive compensation, stock-based compensation, and travel, as well as consultant services, facilities, and laboratory supplies and materials. We expense research and development costs as incurred in the period in which the underlying activity is undertaken.
For periods through the first half of 2021, our research and development expenses include costs associated with developing the CARMA platform principally for a clinical trial that has concluded. As a result of our strategic decision to focus on out-licensing this platform, we will no longer incur any material CARMA-related expenses in future periods.
Research and development expenses decreased by $0.8 million, or 22%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The decrease was primarily driven by a $1.9 million decrease in CARMA expenses as a result of the wind-down of CARMA operations, partially offset by a $0.7 million increase in compensation expenses associated with headcount increases and stock-based compensation and a $0.2 million increase in lab supplies.
We believe that our continued investment in research and development is essential to our long-term competitive position. We expect to continue to incur substantial research and development expenses as we invest in research and development to support our customers, develop new uses for our existing technology and develop improved and/or new offerings for our customers and partners. As a result, we expect that our research and development expenses, excluding CARMA-related expenses, will continue to increase in absolute dollars in future periods and vary from period to period as a percentage of revenue.
Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and Marketing |
|
$ |
2,913 |
|
$ |
1,844 |
|
$ |
1,069 |
|
58% |
|
Our sales and marketing expenses consist primarily of salaries, commissions and other variable compensation, benefits, stock-based compensation and travel costs for employees within our commercial sales and marketing functions, as well as third-party costs associated with our marketing activities.
Sales and marketing expenses increased by $1.1 million, or 58%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The increase was primarily driven by a $0.8 million increase in compensation expenses as a result of increases in headcount, commissions on sales and stock-based compensation primarily due to stock price appreciation and a $0.2 million increase in marketing expenses.
We expect our sales and marketing expenses to increase in future periods as we expand our commercial sales, marketing and business development teams, product offerings, expand our collaboration efforts, increase our presence globally, and increase marketing activities to drive awareness and adoption of our products.
General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
4,622 |
|
$ |
1,594 |
|
$ |
3,028 |
|
190% |
|
General and administrative expenses primarily consist of salaries, benefits, stock-based compensation and travel costs for employees in our executive, accounting and finance, legal, corporate development, human resources, and office administration functions as well as professional services fees, such as consulting, audit, tax and legal fees, general corporate costs, facilities and allocated overhead expenses and costs associated with being an AIM listed public company such as director fees,
General and administrative expense increased by $3.0 million, or 190%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The increase was primarily driven by a $1.8 million increase in compensation expense associated with headcount increases, salary increases and stock-based compensation primarily due to stock price appreciation, and a $1.0 million increase in expenses associated with legal and other professional services.
We expect that our general and administrative expenses will continue to increase in absolute dollars in future periods, primarily due to increased headcount to support anticipated growth in the business and due to incremental costs associated with operating as a public company listed on a
Interest and Other Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense |
|
$ |
13 |
|
$ |
165 |
|
|
($ 152) |
|
(92%) |
|
Interest and other income |
|
$ |
9 |
|
$ |
5 |
|
|
$ 3 |
|
65% |
|
Interest and other income were immaterial in the three months ended June 30, 2021 and 2020. Interest and other expense decreased by $0.2 million, or 92%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The decrease was primarily driven by the repayment of the MidCap loan in March 2021, which resulted in our no longer incurring interest expense on indebtedness. We currently maintain no outstanding debt facility.
Comparison of the Six Months Ended June 30, 2021 and 2020
The following table sets forth our results of operations for the periods presented:
|
|
|
|
|
|
|
|
|
Six Months Ended |
||||
|
|
June 30 |
||||
|
|
2021 |
|
2020 |
||
|
|
(in thousands) |
||||
Total revenue |
|
$ |
13,603 |
|
$ |
10,892 |
Cost of goods sold |
|
|
1,478 |
|
|
1,125 |
Gross profit |
|
|
12,125 |
|
|
9,767 |
Operating expense |
|
|
|
|
|
|
Research and development |
|
|
9,283 |
|
|
8,335 |
Sales and marketing |
|
|
5,702 |
|
|
3,894 |
General and administrative |
|
|
7,930 |
|
|
3,371 |
Total operating expense |
|
|
22,915 |
|
|
15,600 |
Operating loss |
|
|
(10,790) |
|
|
(5,833) |
Other income (expense) |
|
|
|
|
|
|
Interest and other expense |
|
|
(756) |
|
|
(282) |
Interest and other income |
|
|
18 |
|
|
49 |
Total other income (expense) |
|
|
(737) |
|
|
(233) |
Net loss |
|
$ |
(11,527) |
|
$ |
(6,066) |
Revenue
The following table provides details regarding the sources of our revenue for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended, |
|
|
|
|
|
|
||||
|
|
June 30 |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Cell therapy |
|
$ |
9,494 |
|
$ |
6,188 |
|
$ |
3,306 |
|
53% |
|
Drug discovery |
|
|
3,601 |
|
|
2,950 |
|
|
650 |
|
22% |
|
Program-related |
|
|
508 |
|
|
1,754 |
|
|
(1,246) |
|
(71%) |
|
Total revenue |
|
$ |
13,603 |
|
$ |
10,892 |
|
$ |
2,711 |
|
25% |
|
Total revenue for the six months ended June 30, 2021 was $13.6 million, an increase of $2.7 million, or 25%, compared to revenue of $10.9 million during the six months ended June 30, 2020.
Our overall increase in revenue was primarily driven by growth in sales and licenses of instruments and sales of disposables to cell therapy customers, partially offset by a decrease in program-related revenue. In the cell therapy market, the instrument sales and licenses of instruments increased by $2.3 million which was primarily due to continued high levels of capital invested in companies operating in our target markets, while disposable sales increased by $1.0 million as a result of the continued progression of our cell therapy partners' clinical development programs. In the drug discovery market, the $0.7 million increase was primarily driven by a growth resurgence led by the sales of newly introduced multi-well processing assemblies. The $1.2 million decrease in program-related revenues resulted from expected variability from period to period in the level of program-related revenue given the small number of individual triggering events which currently generate this portion of revenue. We expect program-related revenue to experience variability for some time, although we anticipate that it may moderate as the volume of SPLs and associated milestones grows.
Costs of Goods Sold and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
1,478 |
|
$ |
1,125 |
|
$ |
352 |
|
31% |
|
Gross profit |
|
$ |
12,125 |
|
$ |
9,767 |
|
$ |
2,358 |
|
24% |
|
Gross margin |
|
|
89% |
|
|
90% |
|
|
|
|
|
|
Costs of goods sold increased by $0.4 million, or 31%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by higher sales of instruments and disposables.
Gross profit increased by $2.4 million, or 24%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by increased revenue from instrument and disposable sales and licensed instruments.
Operating Expenses
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,283 |
|
$ |
8,335 |
|
$ |
948 |
|
11% |
|
Research and development expenses increased by $0.9 million, or 11%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by a $1.2 million increase in compensation expenses associated with headcount increases and stock-based compensation primarily due to stock price appreciation, a $0.2 million increase in lab supplies and a $0.3 million increase in product development costs and occupancy costs, partially offset by a $0.8 million decrease in CARMA expenses as a result of the wind-down of CARMA operations.
Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and Marketing |
|
$ |
5,702 |
|
$ |
3,894 |
|
$ |
1,808 |
|
46% |
|
Sales and marketing expenses increased by $1.8 million, or 46%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by a $1.8 million increase in compensation expenses as a result of increases in headcount, commissions on sales and stock-based compensation primarily due to stock price appreciation.
General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
7,931 |
|
$ |
3,371 |
|
$ |
4,560 |
|
135% |
|
General and administrative expense increased by $4.6 million, or 135%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by a $2.8 million increase in compensation expense associated with headcount increases, salary increases and stock-based compensation primarily due to stock price appreciation and a $1.4 million increase in expenses including legal and professional services.
Interest and Other Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Six Month Change |
|
|||||||
|
|
2021 |
|
2020 |
|
Amount |
|
% |
|
|||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other expense |
|
$ |
756 |
|
$ |
282 |
|
$ |
474 |
|
168% |
|
Interest and other income |
|
$ |
18 |
|
$ |
49 |
|
|
($ 30) |
|
(62%) |
|
Interest and other income were immaterial in the six months ended June 30, 2021 and 2020. Interest and other expense increased by $0.5 million, or 168%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The increase was primarily driven by the termination fees associated with repayment before maturity of the MidCap loan and the fair value change of common stock warrants.
Liquidity and Capital Resources
Since our inception, we have experienced losses and negative cash flows from operations. For the three and six months ended June 30, 2021, we incurred net losses of $4.4 million and $11.5 million, respectively. As of June 30, 2021, we had an accumulated deficit of $106.7 million. To date, we have funded our operations primarily with proceeds from sales of common stock, borrowings under loan agreements and from revenues associated with sales and licenses of our products to customers. As of June 30, 2021, we had cash and cash equivalents and short-term investments of $73.4 million. On August 3, 2021, we completed our IPO, generating gross proceeds of $201.8 million. We received net proceeds of approximately $184 million after deducting aggregate underwriting commissions and offering expenses of approximately $18 million.
We expect to incur additional operating losses in the future as we continue to invest in expanding our business through growing our sales and marketing efforts, continued research and development, product development and expanding our product offerings. Based on our current business plan, we believe the net proceeds from the IPO, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Our future funding requirements will depend on many factors, including:
· market acceptance of our products;
· the cost and timing of establishing additional sales, marketing and distribution capabilities;
· the cost of our research and development activities and successful development of data supporting use of our products for new applications, and timely launch of new features and products;
· our ability to enter into additional SPLs and licenses for clinical use of our platform in the future;
· changes in the amount of capital available to existing and emerging customers in our target markets;
· the effect of competing technological and market developments; and
· the level of our selling, general and administrative expenses.
If we are unable to execute on our business plan and adequately fund operations, or if the business plan requires a level of spending in excess of cash resources, we will have to seek additional equity or debt financing. If additional financings are required from outside sources, we may not be able to raise such capital on terms acceptable to us or at all.
To the extent that we raise additional capital through the sale of equity or debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our assets, making product acquisitions, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If we are unable to raise additional capital when desired, we may have to delay development or commercialization of future products. We also may have to reduce marketing, customer support or other resources devoted to our existing products.
Cash Flows
The following table summarizes our uses and sources of cash for the periods presented:
|
|
|
|
|
|
|
|
|
Six Months Ended |
||||
|
|
June 30, |
||||
(in thousands, except percentages) |
|
2021 |
|
2020 |
||
Net cash provided by (used in): |
|
|
|
|
|
|
Operating activities |
|
$ |
(9,029) |
|
$ |
(6,040) |
Investing activities |
|
|
(21,230) |
|
|
449 |
Financing activities |
|
|
48,927 |
|
|
28,552 |
Net increase (decrease) in cash and cash equivalents, and restricted cash |
|
$ |
18,668 |
|
$ |
22,961 |
Operating Activities
Net cash used in operating activities for the six months ended June 30, 2021 was $9.0 million, and consisted primarily of our net loss of $11.5 million, offset in part by net non-cash expenses of $4.3 million, including stock-based compensation of $3.2 million, warrant liability fair value adjustments of $0.4 million, and depreciation and amortization expenses of $0.6 million. We also had net cash outflows of $1.7 million due to net changes in our operating assets and liabilities. Net changes in our operating assets and liabilities consisted primarily of an increase in deferred revenue (deferred revenue consists primarily of unrecognized instrument license revenue) of $1.9 million and an decrease in the net effect of our right-of-use assets and lease liabilities of $0.1 million, partially offset by a $1.7 million increase in long-term prepaid expense (other non-current assets), a $1.0 million decrease in accounts payable and accrued expenses, a $0.5 million increase in accounts receivable, a $0.2 million increase in inventory and a $0.3 million increase in other current assets.
Net cash used in operating activities for the six months ended June 30, 2020 was $6.0 million, and consisted primarily of our net loss of $6.1 million, offset in part by non-cash expenses of $1.5 million, including stock-based compensation of $1.1 million and depreciation and amortization expenses of $0.5 million. We also had net cash outflows of $1.5 million due to changes in our operating assets and liabilities. Net changes in our operating assets and liabilities consisted primarily of an increase in deferred revenue of $1.9 million, partially offset by a $2.3 million decrease in accounts payable and accrued expenses, a $0.6 million increase in inventory, a $0.4 million increase in accounts receivable, a $0.1 million increase in other current and non-current assets and a $0.1 million increase in the net effect of our right-of-use assets and lease liabilities.
Investing Activities
Net cash used in investing activities during the six months ended June 30, 2021 was $21.2 million, which was primarily attributable to net purchases of short-term marketable securities of $20.0 million and purchases of property and equipment of $1.2 million.
Net cash provided by investing activities during the six months ended June 30, 2020 was $0.4 million, which was primarily attributable to net maturities of short-term marketable securities of $1.5 million, partially offset by purchases of property and equipment of $1.0 million.
Financing activities
Net cash provided by financing activities during the six months ended June 30, 2021 was $48.9 million, which was primarily attributable to net proceeds of $51.8 million from the issuance of common stock and proceeds of $2.1 million from the exercise of stock options, partially offset by the repayment of the Midcap loan of $4.9 million.
Net cash provided by financing activities during the six months ended June 30, 2020 was $28.6 million, which was primarily attributable to net proceeds of $28.6 million from the issuance of common stock.
Contractual Obligations and Commitments
Our contractual obligations and commitments as of June 30, 2021 consisted of operating lease and finance lease obligations. On May 27, 2021, we entered into an operating lease for new office, lab and warehouse/manufacturing space. The lease for the new facility consists of three phases, with Phase 1 estimated to commence in September 2021, and the lease of all phases is estimated to expire on June 30, 2035. We and the landlord each have a one-time right to terminate Phase 3 of the lease associated with 13,543 square feet during a defined time window. We will design and construct the leasehold improvements with the approval of the landlord. The landlord will reimburse us for costs of property improvements up to amounts specified in the lease. The total incremental non-cancellable lease payments under the new lease agreements are approximately $24.6 million through the lease term.
On June 8, 2021, we exercised our option to early terminate the terms of one of our existing office space lease arrangements. The amended office lease expires on June 7, 2022.
As of June 30, 2021, operating lease obligations included $1.2 million in payments due under our lease of office and laboratory space under operating lease agreements that expire in October 2023. As of June 30, 2021, our finance lease obligations consisted of $0.2 million in payments due for our lease of laboratory equipment under a finance lease that expires in April 2023.
Purchase orders or contracts for the purchase of supplies and other goods and services are based on our current procurement or development needs and are generally fulfilled by our vendors within short time horizons.
Critical Accounting Policies and Significant Judgments and Estimates
We have prepared our condensed consolidated financial statements in accordance with
There have been no material changes to our critical accounting policies and estimates from those disclosed in our consolidated financial statements and the related notes and other financial information included in the Final Prospectus.
JOBS Act Accounting Election
We are an "emerging growth company," or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107 of the JOBS Act provides that an EGC can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of the delayed adoption of new and revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities. We also intend to rely on other exemptions provided by the JOBS Act, including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.
We will remain an EGC until the earliest of (i) December 31, 2026, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more, (iii) the date on which we have issued more than $1 billion in non-convertible debt during the previous rolling three-year period, or (iv) the date on which we are deemed to be a "large accelerated filer" under
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our condensed consolidated financial statements included in this Quarterly Report on Form 10‑Q.
Item 3. Qualitative and Quantitative Disclosures About Market Risk
Interest Rate Risk
We are exposed to market risk for changes in interest rates related primarily to balances of our financial instruments including cash and cash equivalents and short-term investments. As of June 30, 2021, we had cash and cash equivalents and investments of $73.4 million, which consisted primarily of money market funds and commercial paper. The primary objective of our investment approach is to preserve principal and provide liquidity. As of June 30, 2021, we held money market funds securities of $8.7 million, short-term commercial paper of $20.5 million and corporate debt of $2.0 million. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of interest rates in
Foreign Currency Risk
We are exposed to financial risks as a result of exchange rate fluctuations between the
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer, of the effectiveness of our "disclosure controls and procedures" as defined in Rules 13a‑15(e) and 15d‑15(e) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The term "disclosure controls and procedures," as defined in Rules 13a‑15(e) and 15d‑15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the
Based on our evaluation, our Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer concluded that the design and operation of these disclosure controls and procedures were effective as of June 30, 2021 at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended June 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Control systems, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control systems' objectives are being met. Further, the design of any system of controls must reflect the fact that there are resource constraints, and the benefits of all controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of error or mistake. Control systems can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.
Item 1A. Risk Factors.
Our business is subject to numerous risks. You should carefully consider the risks and uncertainties described in this report under the caption "Risk Factors Summary," in addition to other information contained in this report as well as our other public filings with the
There have been no material changes to the risk factors set forth in the Final Prospectus filed with the
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) Sale of Unregistered Securities
From January 1, 2021 through June 30, 2021, we granted options to purchase an aggregate of 2,357,256 shares of our common stock, pursuant to our Long-Term Incentive Plan, as amended, or our LTIP, with a weighted average exercise price of $14.07 per share. From January 1, 2021 through June 30, 2021, certain of our employees exercised options to purchase an aggregate of 1,596,872 shares of our common stock pursuant to options issued under our LTIP, with a weighted average exercise price of $1.30 per share, for an aggregate purchase price of $2,089,300. These issuances were exempt from registration under the Securities Act pursuant to the exemption provided in Rule 701 of the Securities Act.
(b) Use of Proceeds
On August 3, 2021, we closed our IPO, in which we issued and sold 15,525,000 shares of common stock at a price to the public of $13.00 per share, inclusive of 2,025,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares. The IPO generated gross proceeds to us of $201.8 million. We received net proceeds of approximately $184 million after deducting aggregate underwriting commissions and offering expenses of approximately $18 million. All of the shares of common stock issued and sold in the offering were registered under the Securities Act of 1933, as amended ("Securities Act") pursuant to a registration statement on Form S‑1 (File No. 333‑257810), which was declared effective by the
In connection with our IPO, no payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to their associates or to our affiliates. There has been no material change in the planned use of proceeds from the IPO from that described in the Final Prospectus.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
The following exhibits are filed with this Quarterly Report on Form 10‑Q:
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
Incorporated by Reference |
|
|||||||||
Exhibit Number |
|
Description |
|
Form |
|
File No. |
|
Exhibit |
|
Filing Date |
||||
3.1 |
|
|
8‑K |
|
001‑40674 |
|
3.1 |
|
August 4, 2021 |
|||||
3.2 |
|
Fifteenth Amended and Restated Certificate of Incorporation. |
|
S‑1 |
|
333‑257810 |
|
3.1 |
|
July 26, 2021 |
||||
31.1 |
|
|
|
|
|
|
|
|
|
|||||
31.2 |
|
|
|
|
|
|
|
|
|
|
||||
32.1* |
|
|
|
|
|
|
|
|
|
|
||||
32.2* |
|
|
|
|
|
|
|
|
|
|
||||
101.INS |
|
Inline XBRL Instance Document. |
|
|
|
|
|
|
|
|
|
|||
101.SCH |
|
XBRL Taxonomy Extension Schema Document |
|
|
|
|
|
|
|
|
|
|||
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
|
|
|
|
|
|
|||
101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
|
|
|
|
|
|
|||
101.LAB |
|
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
|
|
|
|
|
|
|||
101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
|
|
|
|
|
|
|||
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.SCH, 101.CAL, 101.DEF, 101.LAB and 101.PRE). |
|
|
|
|
|
|
|
|
|
|||
* This exhibit shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in such filings.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
|
|
Date: September 13, 2021 |
By: |
/s/ |
|
|
|
|
Title: |
President and Chief Executive Officer and Director |
|
|
(On Behalf of the Registrant and as Principal Executive Officer) |
|
|
|
|
|
|
Date: September 13, 2021 |
By: |
/s/ |
|
|
|
|
Title: |
Chief Financial Officer (Principal Financial Officer) |
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.